Status:
COMPLETED
Study of Bavituximab in Patients With Chronic Hepatitis C Virus Infection
Lead Sponsor:
Peregrine Pharmaceuticals
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and tolerability of bavituximab when administered via a vein as a single infusion and to examine how bavituximab behaves in the body and how it aff...
Detailed Description
Hepatitis C virus (HCV) infection is a world wide public health concern and is the most common chronic bloodborne infection in the United States and the leading indication for liver transplantation. L...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Chronic hepatitis C infection based on history and detectable serum HCV RNA
- Documented failure to respond to or relapse after treatment with pegylated interferon and ribavirin combination therapy
- Adequate hematologic function (absolute neutrophil count \[ANC\] greater than or equal to 1,500 cells/uL, hemoglobin \[Hgb\] greater than or equal to 12 g/dL in females and greater than or equal to 13 g/dL in males, platelet count greater than or equal to 100,000/uL and less than or equal to 500,000/uL)
- Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 60 mL/min)
- Normal coagulation profile (PT/INR and aPTT within institutional normal limits)
- D-dimer within institutional limits
- Female patients of childbearing potential must have a negative serum pregnancy test at prestudy and all patients of reproductive potential must be willing to use an approved form of barrier method contraception
Exclusion
- Prior exposure to any chimeric antibody
- Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease
- Decompensated clinical liver disease or cirrhosis
- Any evidence of clinically significant bleeding
- Known history of bleeding diathesis or coagulopathy
- Any history of thromboembolic events including central venous catheter-related thrombosis
- Any evidence or history of a hypercoagulable state (eg, elevated d-dimer or shortened aPTT)
- Concurrent therapy with oral or parenteral anticoagulants
- Concurrent hormone therapy (ie, estrogen contraceptives, hormone replacement, anti-estrogen)
- Antiviral therapy within 90 days of day 0
- Investigational therapy within 4 weeks of day 0
- Major surgery within 4 weeks of day 0
- Uncontrolled intercurrent disease
- Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
- A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
- A history of any condition requiring treatment (past or current) with coumarin-type agents
- Cardiac arrhythmia requiring medical therapy
- Serious non-healing wound
- Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
- A disease or concurrent therapy known to cause significant alteration in immunologic function
- Known HIV or active hepatitis B virus (HBV) infection
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00128271
Start Date
August 1 2005
Last Update
May 7 2008
Active Locations (1)
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1
Bach & Godofsky, MD, PA
Bradenton, Florida, United States, 34205